Welcome to our dedicated page for AstraZeneca news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca stock.
AstraZeneca PLC develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
AstraZeneca (NYSE:AZN) reported that tozorakimab met the primary endpoint in both Phase III OBERON and TITANIA trials, reducing the annualized rate of moderate-to-severe COPD exacerbations versus placebo in former smokers and the overall population. Trials randomized 2,306 patients; dosing was 300 mg every four weeks. Tozorakimab was generally well tolerated. Additional Phase III trials PROSPERO (1,713 randomized) and MIRANDA (1,454) are ongoing with results expected in H1 2026.
AstraZeneca (NYSE: AZN) on March 10, 2026 launched the national Get Body Checked Against Cancer public health campaign featuring actor Joshua Jackson and the Philadelphia Flyers mascot Gritty.
The campaign promotes conversations with doctors about cancer risk and screenings, supports Hockey Fights Cancer, and notes a $1.1 million donation to the V Foundation. Visit Getbodychecked.com for resources and screening locations.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo announced the FDA has accepted the sBLA for ENHERTU as post‑neoadjuvant treatment for adults with HER2‑positive early breast cancer and granted Priority Review. The Prescription Drug User Fee Act action date is anticipated in Q3 2026 and the application is under Project Orbis.
Approval is supported by DESTINY‑Breast05 Phase III data showing a 53% reduction in risk of invasive disease recurrence or death (HR 0.47; 95% CI 0.34–0.66) and three‑year IDFS 92.4% vs 83.7% with T‑DM1. Safety highlights include ILD risk and established warnings.
AstraZeneca (AZN) and Daiichi Sankyo announced the FDA has accepted a supplemental BLA and granted Priority Review for ENHERTU as post-neoadjuvant treatment for adult patients with HER2 positive early breast cancer with residual invasive disease. The PDUFA target date is July 7, 2026. DESTINY-Breast05 showed a 53% reduction in risk of invasive disease recurrence or death (HR=0.47) and a three-year IDFS of 92.4% versus 83.7% with T-DM1.
AstraZeneca (NYSE:AZN) announced FDA approval of CALQUENCE plus venetoclax as the first all-oral, fixed-duration (14-cycle, ~14-month) regimen for previously untreated adult CLL/SLL. The AMPLIFY Phase III trial showed 77% progression-free at 3 years vs 67% with chemoimmunotherapy; median PFS was not reached versus 47.6 months and risk of progression/death was reduced by 35% (HR 0.65; p=0.0038).
Safety was consistent with known CALQUENCE risks; no new safety signals identified.
AstraZeneca (AZN) and Daiichi Sankyo announced the EMA validated a Type II Variation application for ENHERTU as monotherapy for adults with HER2 positive early breast cancer with residual invasive disease after neoadjuvant therapy.
The submission is based on DESTINY-Breast05 phase 3 results showing ENHERTU reduced risk of invasive disease recurrence or death by 53% versus T-DM1 and begins CHMP scientific review toward potential EU approval.
AstraZeneca (NYSE: AZN) reported positive Phase III KALOS and LOGOS results showing BREZTRI Aerosphere (BGF 320/28.8/9.6μg) improved lung function and reduced severe asthma exacerbations versus dual ICS/LABA therapy.
In pooled analysis BREZTRI increased trough FEV1 by 76 mL and FEV1 AUC0-3 by 90 mL over 24 weeks; regulatory filings for asthma are under review.
AstraZeneca (NYSE:AZN) awarded $3.4 million through its Accelerate Change Together (ACT) on Health Equity initiative on February 11, 2026, funding 47 nonprofit programs across the US to advance healthcare access, nutrition, lung health and remove barriers to care.
The 2025 awards include 37 Community Solutions Challenge grants of $30,000 each (total $1.11M) and 10 National Strategic Collaborations totaling $2.3M; ACT contributions exceed $18 million to date.
AstraZeneca (NYSE:AZN) reported FY 2025 Total Revenue of $58,739m (up 8% CER) and Core EPS of $9.16 (up 11% CER). Product Revenue was $58,640m. Management declared a second interim dividend of $2.17, raising total FY dividend to $3.20 (up 3%).
FY 2025 included 16 positive Phase 3 readouts, 43 major-region approvals, guidance for mid-to-high single-digit Total Revenue growth and low double-digit Core EPS growth in FY 2026, and a $15bn China investment plan through 2030.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo announced the FDA has accepted the sBLA for DATROWAY (datopotamab deruxtecan-dlnk) and granted Priority Review for 1st-line treatment of unresectable or metastatic triple-negative breast cancer (TNBC) in patients ineligible for PD-1/PD-L1 inhibitors. The FDA action date is anticipated in Q2 2026 under Project Orbis.
Results from TROPION-Breast02 showed a median overall survival improvement of 5.0 months (HR 0.79; 95% CI 0.64-0.98; p=0.0291), a 43% reduction in risk of progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001), ORR 62.5% and DoR 12.3 months versus chemotherapy.